Glevo 500 mg 5 pcs. film-coated tablets

Glevo

The drug is taken orally 1-2 times a day. The tablets should be swallowed whole, without chewing and with a sufficient amount of liquid (0.5 to 1 glass). The drug can be taken before meals or between meals.

Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.

Patients with normal or moderately reduced renal function (creatinine clearance > 50 ml/min)

The following dosage regimen is recommended.

For sinusitis

prescribed 500 mg 1 time/day for 10-14 days.

With exacerbation of chronic bronchitis

- 250 mg or 500 mg 1 time/day for 7-10 days.

For community-acquired pneumonia

- 500 mg 1-2 times/day for 7-14 days.

For uncomplicated urinary tract infections

- 250 mg 1 time/day for 3 days.

For prostatitis

- 500 mg 1 time/day for 28 days.

For complicated urinary tract infections, including pyelonephritis,

- 250 mg 1 time/day for 7-10 days.

For skin and soft tissue infections -

250-500 mg 1-2 times/day for 7-14 days.

For abdominal infections

- 500 mg 1 time/day for 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

In patients with impaired renal function

The following dosage regimen is used.

No additional doses are required after hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

In case of liver dysfunction

no special dosing is required, since levofloxacin is metabolized in the liver only to an extremely small extent.

For elderly patients

no change in dosage regimen is required, except in cases of low QC.

As with the use of other antibiotics, treatment with Glevo is recommended to be continued for at least 48-78 hours after body temperature has normalized or after reliable eradication of the pathogen.

If you miss a dose, you should take the pill as soon as possible before the time for your next dose approaches. Then continue taking the drug according to the schedule.

Glevo 500 mg 5 pcs. film-coated tablets

pharmachologic effect

Antibacterial drug of the fluoroquinolone group with a broad spectrum of action.
Levofloxacin blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, suppresses DNA synthesis, and causes profound morphological changes in the cytoplasm, cell wall and membranes of microorganisms. The drug is active against aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase-negative, including methicillin-sensitive/methicillin-moderately sensitive strains), Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-sensitive strains), Streptococcus spp. groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-sensitive/moderately sensitive/resistant strains), Streptococcus pyogenes, Streptococcus viridans (penicillin-moderately sensitive/resistant strains); aerobic gram-negative microorganisms: Acinetobacter spp. (including Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (including Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-sensitive/resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (producing and non-producing β-lactamases), Morganella morganii, Neisseria gonorrhoeae (producing and non-producing penicillinase), Neisseria meningitidis, Pasteurella spp. (including Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Salmonella spp., Serratia spp. (including Serratia marcescens); anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterium spp., Veilonella spp.; other microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp., Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

Composition and release form Glevo 500 mg 5 pcs. film-coated tablets

Tablets - 1 tablet:

• Active substance: levofloxacin (in the form of hemihydrate) 500 mg.
• Excipients: microcrystalline cellulose, povidone (povidone K-30), crospovidone, magnesium stearate, microcrystalline cellulose (Avicel pH101).
• Film shell composition: hypromellose, macrogol (polyethylene glycol 6000), dibutyl phthalate, talc, titanium dioxide, red iron oxide dye, yellow iron oxide dye.

5 pieces. — cellular contour packages (1) — cardboard packs.

Description of the dosage form

Tablets, film-coated, light orange with a pink tint, biconvex, oblong-shaped, with a break line on one side; Slight surface roughness of the tablets is allowed.

Directions for use and doses

The drug is taken orally 1-2 times a day. The tablets should be swallowed whole, without chewing and with a sufficient amount of liquid (0.5 to 1 glass). The drug can be taken before meals or between meals.

Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.

For patients with normal or moderately reduced renal function (creatinine clearance >50 ml/min), the following dosage regimen is recommended.

For sinusitis, prescribe 500 mg 1 time / day for 10-14 days.

For exacerbation of chronic bronchitis - 250 mg or 500 mg 1 time / day for 7-10 days.

For community-acquired pneumonia - 500 mg 1-2 times a day for 7-14 days.

For uncomplicated urinary tract infections - 250 mg 1 time / day for 3 days.

For prostatitis - 500 mg 1 time / day for 28 days.

For complicated urinary tract infections, including pyelonephritis, 250 mg 1 time / day for 7-10 days.

For infections of the skin and soft tissues - 250-500 mg 1-2 times a day for 7-14 days.

For infections of the abdominal cavity - 500 mg 1 time / day for 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

No additional doses are required after hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

If liver function is impaired, no special dose adjustment is required, since levofloxacin is metabolized in the liver only to an extremely small extent.

For elderly patients, no change in dosage regimen is required, except in cases of low QC.

As with the use of other antibiotics, treatment with Glevo is recommended to be continued for at least 48-78 hours after body temperature has normalized or after reliable eradication of the pathogen.

If you miss a dose, you should take the pill as soon as possible before the time for your next dose approaches. Then continue taking the drug according to the schedule.

Pharmacokinetics

Suction

When taken orally, it is quickly and almost completely absorbed. Food intake has little effect on the speed and completeness of absorption. Bioavailability - 99%. Tmax - 1-2 hours. When taking the drug in doses of 250 mg and 500 mg, Cmax is 2.8 mcg/ml and 5.2 mcg/ml, respectively.

Distribution

Plasma protein binding is 30-40%. Penetrates well into organs and tissues (lungs, bronchial mucosa, sputum, genitourinary organs, polymorphonuclear leukocytes, alveolar macrophages).

Metabolism

In the liver, a small part of the drug is oxidized and/or deacetylated.

Removal

Renal clearance accounts for 70% of the total clearance. T1/2 - 6-8 hours. Excreted from the body mainly by the kidneys through glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. After oral administration, about 70% of the dose is excreted unchanged in the urine within 24 hours, about 87% of the dose is excreted within 48 hours; less than 4% - in feces within 72 hours.

Indications for use Glevo 500 mg 5 pcs. film-coated tablets

Bacterial infections caused by microorganisms sensitive to the drug in adults:

• acute sinusitis;
• exacerbation of chronic bronchitis;
• community-acquired pneumonia;
• uncomplicated urinary tract infections;
• complicated urinary tract infections (including pyelonephritis);
• chronic bacterial prostatitis;
• skin and soft tissue infections;
• septicemia/bacteremia associated with the above indications;
• abdominal infections;
• comprehensive treatment of drug-resistant forms of tuberculosis.

Contraindications

• Epilepsy;
• tendon damage due to previous treatment with quinolones;
• pregnancy;
• lactation period (breastfeeding);
• childhood and adolescence (up to 18 years);
• hypersensitivity to levofloxacin and other fluoroquinolones.

The drug should be prescribed with caution to elderly patients (due to the high likelihood of a concomitant decrease in renal function) and with glucose-6-phosphate dehydrogenase deficiency.

Application of Glevo 500 mg 5 pcs. film-coated tablets during pregnancy and breastfeeding

The use of the drug is contraindicated during pregnancy and lactation.

Use in children

Contraindication: childhood and adolescence (up to 18 years).

special instructions

Although levofloxacin is more soluble than other quinolones, patients should be kept adequately hydrated.

During treatment, it is necessary to avoid solar and artificial UV irradiation to avoid damage to the skin (photosensitization).

If signs of tendonitis or pseudomembranous colitis appear, levofloxacin is immediately discontinued and appropriate therapy is prescribed.

It should be borne in mind that in patients with a history of brain damage (stroke, severe trauma), seizures may develop; with glucose-6-phosphate dehydrogenase deficiency, the risk of hemolysis increases.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms: nausea, erosive lesions of the gastrointestinal mucosa, prolongation of the QT interval, confusion, dizziness, convulsions.

Treatment: symptomatic therapy is carried out, dialysis is not effective.

Side effects Glevo 500 mg 5 pcs. film-coated tablets

The side effects listed below are presented in accordance with the following gradations of frequency of their occurrence: very often (≥1/10), often (≥1/100,

Drug interactions

With simultaneous use, levofloxacin increases T1/2 of cyclosporine.

The effect of the drug is reduced by drugs that inhibit intestinal motility, sucralfate, aluminum/magnesium-containing antacid drugs and iron salts (a break of at least 2 hours is required between doses).

With simultaneous use of Glevo with NSAIDs and theophylline, convulsive readiness increases.

When Glevo is used simultaneously with GCS, the risk of tendon rupture increases.

Cimetidine and drugs that block tubular secretion slow down the elimination of levofloxacin.

With the simultaneous use of hypoglycemic drugs with levofloxacin, hypo- and hyperglycemia may develop. Therefore, strict control of blood glucose levels is necessary.

Some aspects of the use of the drug Glevo in the treatment of bronchopulmonary diseases

Over the past 30 years, the number of patients with bronchopulmonary diseases has increased by 50%, and diseases in the initial stage and mild course are recorded in only a quarter of cases. The remaining 75% are accounted for by moderate and severe forms of pathology. Among bronchopulmonary diseases, infectious and inflammatory diseases most often lead to temporary disability: bronchitis, pneumonia, pleurisy, etc. Therefore, timely diagnosis and effective treatment of these diseases are the main tasks of modern pulmonology. One of the drugs that has proven itself to be the drug of choice in the treatment of the above diseases is the antibiotic Glevo. The drug is produced and registered in the Russian Federation in 2008. The drug is highly effective against a large number of anaerobic and aerobic gram-positive and gram-negative pathogens. The effectiveness of Glevo is based on its active ingredient levofloxacin, which belongs to modern drugs from the group of third-generation fluorinated quinolones, which have a bactericidal effect and a wide spectrum of antimicrobial activity, which allows the drug to be used in the treatment of infections of various localizations. The mechanism of the bactericidal effect of levofloxacin is the suppression of bacterial topoisomerase IV and DNA gyrase (type II topoisomerase), enzymes necessary for replication, transcription, repair and recombination of bacterial DNA. The drug causes significant morphological changes in the cell wall, nucleus and cytoplasm of bacterial cells. Range of application of the drug The high efficiency and wide spectrum of action of the drug allow it to be used in the treatment of many infectious and inflammatory diseases of various localizations and etiologies in the adult population (over 18 years of age). Among them are diseases of the ENT organs, bronchi and lungs, inflammation of the genital organs, diseases of the excretory system, infections of the abdominal cavity, diseases of the skin, soft tissues, etc. Cases of side effects when using Glevo are quite rare. Mostly, patients taking Glevo experience dyspeptic disorders and symptoms of intestinal dysbiosis. The number of side effects with short-term use of the drug is extremely small. The main contraindications to taking Glevo can be considered hypersensitivity to its active substance - levofloxacin and other fluoroquinolone drugs. In addition, Glevo should not be used in patients with epilepsy, in childhood and adolescence, during pregnancy and lactation. It is not recommended to take an antibiotic if the patient has previously used quinolones for treatment and there has been tendon damage. In geriatric practice, due to possible changes in kidney function and in case of deficiency of glucose-6-phosphate dehydrogenase, it is advisable to take the drug under special supervision. Dosage and pharmacokinetics of the drug The dosage of the antibiotic is extremely convenient: Glevo is available in the form of tablets. It is recommended to take the drug 1 time/day. (in extremely rare cases – 2 times/day) for 5–10 (rarely 14–28) days. During the course of antibiotic therapy, doctors recommend taking the tablet with a sufficient amount of water, consuming plenty of fluids during the day, not sunbathing in the sun and not going to the solarium. When the antibiotic is administered orally, Glevo is absorbed in the shortest possible time, regardless of food intake. The experimentally proven bioavailability of the drug is almost 99%. The antibiotic instantly binds to plasma protein fractions and enters tissues and organs, producing a bactericidal effect. Glevo does not put a strain on the liver, since 70% of the drug is taken in 1 day. and 87% – in the 2nd day. excreted by the kidneys. Features of the use of the drug in pulmonology "Levofloxacin Glenmark" showed the greatest effectiveness when treated with high doses in a short course. These data were obtained during a randomized, multicenter, double-blind study conducted by the department of the University of Louisiana (USA) and employees of Ortho-McNeil Pharmaceutical in patients with community-acquired pneumonia of varying severity. The effects of taking Levofloxacin Glenmark once a day were compared: 750 mg for 5 days. and 500 mg for 10 days. The effectiveness of therapy was assessed by clinical and microbiological indicators. The study found that against the background of almost identical clinical effectiveness of therapy (92.4 versus 91.1%), patients who took the antibiotic for 10 days had a higher risk of disease relapse (4.3 versus 1.2%) . In addition, in those who took a short course of treatment, improvement and reduction in symptoms of inflammation appeared much earlier - already by the 3rd day of treatment. There were few side effects when taking the antibiotic; their number was the same in both groups. Conclusions The range of applications of Glevo is very wide, which allows it to be considered both a drug of choice and a reserve remedy in case of insufficient effectiveness of antibacterial agents of other classes. The breadth of antibacterial action, bactericidal activity and excellent pharmacokinetic characteristics (high bioavailability, degree of penetration into organs and tissues) allow us to classify levofloxacin as an effective and safe antibacterial chemotherapeutic agent. A special place is given to this drug in the treatment of community-acquired pneumonia and chronic bronchitis. Glevo is highly effective with minimal risk of side effects. It is also advisable to use the drug for the treatment of pneumonia with concomitant diseases. In atypical (legionella) pneumonia, levofloxacin has shown high effectiveness; in these cases, combination antibacterial therapy, for example, with rifampicin, is most appropriate. In Russian national recommendations, levofloxacin is assigned the role of an alternative antibiotic (in relation to the group of macrolides). Literature 1. Golofeevsky V. Yu. On the effectiveness of Levofloxacin in eradication therapy regimens for Helicobacter pylori infection // Terra Medica Nova. 2009. No. 4–5. 2. Maev I.V., Samsonov A.A., Andreev N.G., Kochetov S.A. Clarithromycin as the main element of eradication therapy for diseases associated with Helicobacter pylori infection // Gastroenterology. 2011. No. 1. 3. Minushkin O., Zverkov I., Volodin D., Shindina T., Safronov A., Chebotareva A. Eradication therapy for duodenal ulcer // Doctor. 2008. No. 9. pp. 1–3. 4. Dunbar LM et al. High-dose, short-course levofloxacin for community-acquired pneumonia: a new treatment paradigm // Clin. Infect. Dis. 2003. Vol. 37(6). R. 752–760. 5. Guillaume M., Garraffo R., Bensalem M. Pharmacokinetic and dynamic study of levofloxacin and rifampicin in bone and joint infections // Med Mal Infect. 2012. Sep. Vol. 42(9). R. 414–420. 6. Lee JH, Kim SW, Kim JH, Ryu YJ, Chang JH High-dose levofloxacin in community-acquired pneumonia: a randomized, open-label study // Clin Drug Investig. 2012. Sep 1. Vol. 32(9). R. 569–576. 7. Torres A., Liapikou A. Levofloxacin for the treatment of respiratory tract infections // Expert Opin Pharmacother. 2012. Jun. Vol. 13 (8). R. 1203–1212. 8. The US Food and Drug Administration (FDA) approved Glenmark's levofloxacin (250, 500 and 750 mg film-coated tablets) for use in the US (June 20, 2011)